Log In to CK+

Pharmacovigilance Manager Job

October 2, 2009

We are currnely recruiting for Pharmacovigilance Manager.

Background

We are currently recruiting for a Manager of Pharmacovigilance with a very dynamic consultancy. This is an exciting opportunity to set up and lead a new Pharmacovigilance department. You will be responsible for providing leadership in all Pharmacovigilance matters, training drug safety people internally, and acting as the main point of contact for clients relating to Pharmacovigilance matters and implementing SOPs. There is potential to move to a Directorship role, with shares in the business and potential to be trained as a QP.

Key responsibilities

– Running the Drug Safety team on a day-to-day basis.

– Provide leadership and training in all pharmacovigilance matters.

– Allocation of work to relevant team members.

Your supervisory responsibilities will include:

– Leading and training other members of the team in the Grantham office.

– As additional team members join also responsible for managing them.

– Help manage department growth and assist in the managing the department’s budget.

The Day to day duties of the role:

– Point of contact for clients relating to pharmacovigilance matters

– Training other team members

– Managing case load

– PSUR writing as required

– SAE narrative writing asrequired

– To perform SAE reconciliation

– Good awareness and knowledge of ABPI code of practice and its application

– Triage in-coming Pharmacovigilance reports in accordance to their seriousness and regulatory context

– To perform^follow-up activities for Pharmacovigilance Reports

– Ensures all projects meet targets and deadlines

– Ensuring procedures are in place and are followed

– Signal generation.

– To ensure that such activities are performed to high standards of quality and timeliness in line with the best industry standards.

– Compliance to SOP’s, processes, practices and guidelines

Training and development

There is the potential to move into a Directorship role with Shares in the business. Potential to be trained as a QP

Qualifications:

– Life science or

– Technically competent in performing similar function in either a Pharmaceutical or CRO environment

– Good written and verbal communication

– Ability to prioritise workloads and to negotiate and meet deadlines

– Commercial awareness

– Customer focused

– Team player

– Flexible approach

To Apply

If you expect more than just a great salary and benefits package and believe you can make an impact in this innovative and cutting edge business, then please contact Hendre on Tel: +44 (0)1438 743047 or email me at hmoolman@cklinical.co.uk quoting reference 16613.